3.1 NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 8 sources, which was discussed by the committee. The evidence included 3 cohort studies, 2 non-randomised comparative studies, 2 case series and 1 case report. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The professional experts and the committee considered the key efficacy outcomes to be: aortic-related pathology (including dissection and dilation), need for aortic valve replacement, and anxiety about progressive aortic disease.
3.3 The professional experts and the committee considered the key safety outcomes to be: bleeding, infection and atrial fibrillation.
3.4 Thirteen commentaries from people who have had this procedure were discussed by the committee. Everyone who responded said that they would recommend the procedure to someone else with their condition. Several noted the benefit of not having to take anticoagulants for the rest of their lives.
3.5 The committee was informed that surgeons receive proctoring for their first few procedures.
3.6 The committee encourages the establishment of a registry for this procedure.
3.7 The procedure is used for other aortopathies as well as Marfan syndrome.
3.8 The committee was informed that, in common with valve-sparing aortic root replacement, patients may need further surgery on the aortic valve at a later date.
3.9 The committee was informed that the procedure can be used alongside other procedures.